Paraguay approves the Emergency Use Authorization
(EUA) of MVC COVID-19 Vaccine
Date of events
2022/02/14
To which item it meets
paragraph 10
Statement
1.Date of occurrence of the event:2022/02/14
2.New drug name or code:MVC COVID-19 Vaccine
3.Indication:Prevent COVID-19 infection
4.Planned development stages:apply for Emergency Use Authorization (EUA) in
various countries; pursue relative clinical studies and post-marketing
surveillance
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical
trials(include interim analysis):
On 2022/2/14, Paraguay's regulatory authority, DINAVISA, announced the
approval of Emergency Use Authorization (EUA) to MVC COVID-19 Vaccine.
The company cooperated with University of Asuncion in mid 2021 to conduct
the phase 3 clinical trial of MVC COVID-19 Vaccine in Paraguay to
demonstrate the superiority to AZ COVID-19 vaccine. The interim analysis
was completed in 2022/02/14.
DINAVISA has completed the on-site inspection of the factory and reviewed
the pharmacology and toxicology/animal study results, the phase 1 and phase
2 clinical trial results in Taiwan, the phase 3 clinical trial results in
Paraguay, the chemical manufacturing control (CMC) and other technical
documents and then give the official approval of the Emergency Use
Authorization (EUA) to MVC COVID-19 Vaccine in Paraguay in 2022/02/14.
(2)Once disapproved by competent authority or each of clinical trials
(include interim analysis) results less than statistically
significant sense, the risks & the associated measures the Company
may occur:N/A
(3)After obtaining official approval or the results of statistically
significant sense, the future strategy:evaluate the vaccine demand and then
supply to the target market
(4)Accumulated investment expenditure incurred:Based on business strategy
considerations, it will not be disclosed for the time being.
6.Upcoming development plan:
(1)Estimated date of completion:Continue to conduct the relevant clinical
verifications to obtain the drug permit license.
(2)Estimated responsibilities:All relevant fees for the registration of
new drug application.
7.Market situation:
According to Our World in Data, 62.3% of the world's population has received
at least one dose of COVID-19 vaccine, 54.4% are fully vaccinated and 15.1%
has received the 3rd booster dose. The total number of vaccine doses
administered has exceeded 10.4 billion. Based on the demand for primary
series and 3rd booster dose, WHO estimated that there is still a global
demand of more than 10 billion doses of COVID-19 vaccines. The situation
of global shortage and inequality of COVID-19 vaccines may not be relieved
in the short term.
8.Any other matters that need to be specified:None
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks.The investors
are advised to exercise caution and conduct thorough evaluation.:
